Weight Bearing for Fibular Fractures

Overview

It is common practice to restrict weight bearing after ankle fracture open reduction and internal fixation (ORIF) until week 6 postoperatively. However, controversy exists surrounding the optimal postoperative protocol. At our institution, all ankle fractures are made non-weight bearing for 6 weeks across the board. Isolated lateral malleolar fractures after ORIF may benefit from earlier weight bearing in terms of patient satisfaction, short-term functionality, and return to work. The purpose of this study is to determine if early weight bearing at 2 weeks postoperatively for isolated lateral malleolar fractures leads to a higher satisfaction with surgery as compared to standard protocol for postoperative ankle fractures and better functional outcomes

Full Title of Study: “Early Weight Bearing for Isolated Fibular Fractures: A Prospective Randomized Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 20, 2021

Interventions

  • Device: Controlled Ankle Motion (CAM) boot
    • A CAM boot will be worn on the affected ankle to allow weight bearing
  • Procedure: Physical Therapy
    • Standard physical therapy protocol will be started at 6 weeks after surgery

Arms, Groups and Cohorts

  • Active Comparator: Early weight bearing
    • Participants treated for an ankle fracture will be allowed to weight bear early after surgery starting at 2 weeks post operatively
  • Active Comparator: Postponed weight bearing
    • Participants treated for an ankle fracture will be treated with standard protocol of non-weight bearing for 6 weeks post operatively.

Clinical Trial Outcome Measures

Primary Measures

  • Participant Satisfaction with treatment #1
    • Time Frame: 24 weeks
    • Participant satisfaction will be measured using the Short Form-12 survey (SF-12)
  • Participant Satisfaction with treatment #2
    • Time Frame: 24 weeks
    • Participant satisfaction will be measured using the Foot and Ankle Ability Measure (FAAM) scores
  • Participant Pain after surgery
    • Time Frame: 24 weeks
    • Participant Pain will be measured using the Visual Analog Scale for Pain (VAS) score

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients (age>18) undergoing surgical treatment for isolated lateral malleolar fracture with foot and ankle surgeons at the Rothman Orthopaedic Institute Exclusion Criteria:

  • Patients requiring other fracture fixation, deltoid ligament repair, or syndesmosis fixation – Revision ankle fracture cases – Pre-existing impaired mobility, – Pre-existing cognitive disability, – Open fractures, – BMI >40, – Diabetes mellitus (DM)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rothman Institute Orthopaedics
  • Provider of Information About this Clinical Study
    • Sponsor

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